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Patients who underwent multivessel percutaneous coronary intervention and were treated with dual antiplatelet therapy for 1 month, followed by ticagrelor monotherapy for 23 months, were found to be at reduced risk for all-cause mortality, when compared with the current standard of care, according to a study published in the Journal of the American College of Cardiology.
In this study, data from the prospective open-label randomized controlled GLOBAL LEADERS trial (GLOBAL LEADERS; ClinicalTrials.gov identifier: NCT01813435) were analyzed. Participants in this trial were randomly assigned to receive dual antiplatelet therapy for 1 month followed by 23 months of ticagrelor monotherapy (experimental condition; n=1802), or 12-month of dual antiplatelet therapy followed by 12 months of aspirin monotherapy (reference group; n=1774).
A significant lesion was defined as >1 coronary artery stenosis of ≥50%. The study’s primary and secondary end points for efficacy were a composite of all-cause death or new Q-wave myocardial infarction at 2 years, and bleeding type 3 or 5, according to the Bleeding Academic Research Consortium at 2 years, respectively.
At 1 year, 82.7% and 89.5% of patients in the experimental and reference groups, respectively were found to adhere to the protocol. At 2 years, 78.3% of patients in the experimental group adhered to protocol. Dyspnea was more common in participants receiving the experimental vs reference treatment (17.70% vs 10.48%, respectively; P <.001).
Patients receiving the experimental vs reference treatment were found to have a lower risk for all-cause death or new Q-wave myocardial infarction (3.06% vs 4.85%, respectively; hazard ratio [HR], 0.62; 95% CI, 0.44-0.88; P =.006), and a comparable risk for type 3 or 5 bleeding (2.47% vs 2.68%, respectively; HR, 0.92; 95% CI, 0.61-1.39; P =.685). When assessing the subgroup of patients with stable coronary artery disease who underwent multivessel percutaneous coronary intervention, those treated with the experimental vs reference treatment had a lower risk for all-cause mortality or new Q-wave myocardial infarction (3.15% vs 4.41%, respectively; HR, 0.71; 95% CI, 0.44-1.16; P =.17), and a higher risk for type 3 or 5 bleeding (2.70% vs 1.51%, respectively; HR, 1.81; 95% CI, 0.59-3.63; P =.103). When assessing the subgroup of patients with acute coronary syndrome who underwent multivessel percutaneous coronary intervention, patients treated with the experimental vs reference treatment had a lower risk for all-cause mortality or new Q-wave myocardial infarction (2.95% vs 5.26%, respectively; HR, 0.55; 95% CI, 0.35-0.89; P =.014), and a lower risk for type 3 or 5 bleeding (2.19% vs 3.73%, respectively; HR, 0.58; 95% CI, 0.33-1.01; P =.053).
Study limitations include the post hoc nature of the analysis, the inclusion of a single type of stent, and the lack of a mandated physiologic assessment protocol for lesions.
“In patients undergoing multivessel [percutaneous coronary intervention], 1 month of [dual antiplatelet therapy] with aspirin plus ticagrelor followed by 23 months of ticagrelor monotherapy was associated with a lower risk [for] the composite of all-cause mortality or new Q wave myocardial infarction compared with a conventional regimen of 12 months of [dual antiplatelet therapy] followed by 12 months of aspirin monotherapy with no increase in major bleeding,” concluded the study authors/
Disclosure: The GLOBAL LEADERS clinical trial was supported by AstraZeneca, Biosensors, and The Medicines Company. Please see the original reference for a full list of authors’ disclosures.
Reference
Takahashi K, Serruys PW, Chichareon P, et al. Efficacy and safety of ticagrelor monotherapy in patients undergoing multivessel PCI. J Am Coll Cardiol. 2019;74(16):2015-2027.
